Chemical formula: C₁₇H₁₅N₃O₆ Molecular mass: 357.318 g/mol PubChem compound: 6335412
Human experience with balsalazide is limited, therefore it should not be given to pregnant women.
Balsalazide should not be given to breast feeding women as the active metabolite mesalazine has produced adverse effects in nursing infants.
Animal studies on fertility and reproductive function did not reveal adverse effects of balsalazide.
Balsalazide has no or negligible influence on the ability to drive and use machines.
The adverse effects are expected to be those of mesalazine.
Reactions reported during treatment with oral mesalazine are listed in the table below.
| Organ group | Adverse Event |
|---|---|
| Blood and lymphatic system disorders | Blood dyscrasias Aplastic anaemia Leucopenia Neutropenia Agranulocytosis Thrombocytopenia |
| Nervous system disorders | Headache Neuropathy |
| Cardiac disorders | Myocarditis Pericarditis |
| Respiratory, thoracic and mediastinal disorders | Bronchospasm Allergic alveolitis Eosinophilic pneumonia |
| Gastrointestinal disorders | Abdominal pain Diarrhoea Nausea, vomiting Aggravation of ulcerative colitis Acute pancreatitis |
| Hepatobiliary disorders | Hepatitis Cholelithiasis |
| Skin and subcutaneous tissue disorders | Alopecia Angioedema Rash |
| Musculoskeletal and connective tissue disorders | Systemic lupus erythematosus-like syndrome Arthralgia Myalgia |
| Renal and urinary disorders | Interstitial nephritis Acute renal failure Renal insufficiency Renal impairment |
| Immune system disorders | Hypersensitivity |
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